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UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
7-hydroxystaurosporine
topotecan hydrochloride
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer, stage III ovarian epithelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer Progressive, persistent, or recurrent disease Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy Tumor lesions accessible for biopsy Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator No more than 2 prior chemotherapy regimens At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin) No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine no greater than ULN OR Creatinine clearance at least 50 mL/min Cardiovascular No history of coronary artery disease No symptomatic cardiac dysfunction No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram Pulmonary No symptomatic pulmonary dysfunction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 8 weeks after study participation No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents No insulin-dependent diabetes mellitus Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy and recovered Chemotherapy See Disease Characterisitcs More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior topotecan No other prior topoisomerase I inhibitors Endocrine therapy More than 4 weeks since prior hormonal therapy and recovered Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 40% of bone marrow No prior mediastinal irradiation Surgery More than 4 weeks since prior surgery and recovered Other No other concurrent anticancer therapy No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • Margaret and Charles Juravinski Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Ottawa Regional Cancer Centre
  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 4, 2003
Last Updated
July 22, 2015
Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00072267
Brief Title
UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
Official Title
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Detailed Description
OBJECTIVES: Primary Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer. Secondary Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients. Determine the progression-free, median, and overall survival of patients treated with this regimen. Determine the safety and tolerability of this regimen in these patients. Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer, primary peritoneal cavity cancer, fallopian tube cancer, stage III ovarian epithelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
7-hydroxystaurosporine
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer Progressive, persistent, or recurrent disease Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy Tumor lesions accessible for biopsy Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator No more than 2 prior chemotherapy regimens At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin) No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine no greater than ULN OR Creatinine clearance at least 50 mL/min Cardiovascular No history of coronary artery disease No symptomatic cardiac dysfunction No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram Pulmonary No symptomatic pulmonary dysfunction Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 8 weeks after study participation No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents No insulin-dependent diabetes mellitus Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator No other concurrent uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior biologic therapy and recovered Chemotherapy See Disease Characterisitcs More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No prior topotecan No other prior topoisomerase I inhibitors Endocrine therapy More than 4 weeks since prior hormonal therapy and recovered Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No prior radiotherapy to more than 40% of bone marrow No prior mediastinal irradiation Surgery More than 4 weeks since prior surgery and recovered Other No other concurrent anticancer therapy No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hal W. Hirte, MD, FRCP(C)
Organizational Affiliation
Margaret and Charles Juravinski Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Regional Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

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